FDA 510(k) Application Details - K003649

Device Classification Name	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented   More FDA Info for this Device
510(K) Number	K003649
Device Name	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
Applicant	HAYES MEDICAL, INC. 1115 WINDFIELD WAY, SUITE 100 EL DORADO HILLS, CA 95762-9623 US Other 510(k) Applications for this Company
Contact	WILLIAM J GRIFFIN Other 510(k) Applications for this Contact
Regulation Number	888.3360   More FDA Info for this Regulation Number
Classification Product Code	LWJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/27/2000
Decision Date	02/23/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review